Study Completed

Diabetes Mellitus

Bayer Identifier:

13066

ClinicalTrials.gov Identifier:

NCT01167231

EudraCT Number:

Not Available

EU CT Number:

Not Available

Prevention of postprandial hyperglycemia by acarbose may be a promising therapeutic strategy for reducing the increased risk for cardiovascular disease

Trial purpose

The use of acarbose in impaired glucose tolerance (IGT) and type 2 diabetic subjects has been associated with a significant reduction of cardiovascular events. Additionally, acarbose has been shown to have a beneficial influence on some of the other cardiovascular risk factors (metabolic syndrome components). Thus, prevention of postprandial hyperglycemia by acarbose may be a promising therapeutic strategy for reducing the increased risk for cardiovascular disease. Further studies are needed to confirm the influence of acarbose on cardiovascular risk factors in the real life setting.

Key Participants Requirements

Sex

Both

Age

18 - N/A

Inclusion Criteria
- Diabetes Mellitus
- Age >/= 18 years
- Naive to acarbose (minimum 3 months before inclusion)
Exclusion Criteria
- Hypersensitivity to acarbose or any of the excipients
- Age <18 years
- Pregnancy and in nursing
- Inflammatory bowel disease, colonic ulceration, partial intestinal obstruction or in patients predisposed to intestinal obstruction
- Chronic intestinal diseases associated with marked disorders of digestion or absorption
- States which may deteriorate as a result of increased gas formation in the intestine, (e.g. Roemheld’s syndrome [an angina pectoris-like syndrome or aggravation of an angina pectoris due to the postprandial filling of the stomach] and larger hernias)
- Hepatic and severe renal impairment (creatinine clearance <25 mL/min/ 1,73m2)

Trial summary

Enrollment Goal

3310

Trial Dates

May 2007 - June 2008

Phase

N/A

Could I Receive a placebo

Products

Acarbose (Precose/Glucobay, BAYG5421)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Many Locations, Poland

Primary Outcome

Safety, tolerability of acarbose and its effect on body weight, waist circumference and blood pressure
Time Frame:
approximately 6 months after acarbose treatment initiation
Safety Issue:
No

Secondary Outcome

Effect of acarbose on HbA1c, fasting and postprandial glycemia and on lipid profile
Time Frame:
approximately 6 months after acarbose treatment initiation
Safety Issue:
Yes

Trial design

Acarbose in cardiovascular risk management. Assessment of clinical efficacy and safety of acarbose and its effect on selected cardiovascular risk factors in type 2 diabetes patients.

Trial Type

Observational

Intervention Type

Drug

Trial Purpose

N/A

Allocation

N/A

Blinding

N/A

Assignment

N/A

Trial Arms

N/A

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to marketed products.